CHILLS and Gabapentin

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CHILLS Symptoms and Causes

Plague is an infection caused by the bacterium Yersinia pestis. The bacteria are found mainly in rats and in the fleas that feed on them. People and other animals can get plague from rat or flea bites. In the past, plague destroyed entire civilizations. Today plague is uncommon, due to better living conditions and antibiotics.

CHILLS Clinical Trials and Studies

Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.

Number of participants with death or poor neurologic outcome at 6 months; Number of mortality; Number of participants with stroke; Number of participants with bleeding; Length of stay in the unit; Length of stay in the hospital; Number of participants with cardiogenic shock; Number of participants with repeat circulatory arrest requiring cardiopulmonary resuscitation (CPR); Number of participants with seizures; Number of participants with renal failure requiring renal replacement therapy; Number of participants with ventilator associated pneumonia; Number of participants with stent thrombosis; Number of participants discharged home

Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected; Proportion of non-cirrhotic HCV GT-1b subjects with eRVR, defined as HCV RNA < LLOQ target not detected; Proportion of non-cirrhotic HCV GT-1b subjects with treatment-emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3, and/or thrombocytopenia as defined by platelets < 50,000 mm3) on treatment; Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated flu-like symptoms (pyrexia or CHILLS or pain); Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated musculoskeletal symptoms (arthralgia or myalgia or back pain); Proportion of non-cirrhotic HCV GT-1b subjects with SVR24, defined as HCV RNA < LLOQ target detected or not detected; Frequency of deaths among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks); Frequency of Serious adverse events (SAEs) among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks); Frequency of drug related Adverse events (AEs) among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks); Frequency of dose reductions and discontinuations due to AEs among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks); Frequency of treatment emergent laboratory abnormalities among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks); Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated constitutional symptoms (fatigue or asthenia) through the end of treatment (maximum of 12 weeks); Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated neurologic symptoms (headache or dizziness) through the end of treatment (maximum of 12 weeks); Proportion of non-cirrhotic HCV GT-1b subjects with psychiatric symptoms (depression or irritability or insomnia) through the end of treatment (maximum of 12 weeks)

To compare the immune responses to mycobacterial antigens, including PPD and Mycobacterium tuberculosis culture filtrate protein, in individuals who are LTBI+ Fil- versus those who are LTBI+ Fil+.; To compare immune responses to mycobacterial antigens in LTBI+Fil+ co-infected individuals, before and after treatment for filarialinfection.

Antiviral activity, as determined by the proportion of subjects with SVR12, defined as HCV RNA <LLOQ (25 IU/mL), target detected or target not detected, for each treatment arm; Proportion of subjects with Rapid virologic response (RVR) and Extended Rapid Virologic Response (eRVR), where RVR is defined as <LLOQ target not detected at week 4 and eRVR defined as <LLOQ target not detected at Weeks 4 and 12; Proportion of subjects in each group/duration who achieve HCV RNA <LLOQ target detected or not detected, at end of therapy (SVR24); Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb <10 g/dL, and/or neutropenia as defined by ANC <750 mm3 and/or thrombocytopenia as defined by platelets <50,000 mm3) during the treatment period; Proportion of subjects with the following on treatment IFN-associated symptoms: flu-like symptoms (as defined by pyrexia or CHILLS or pain) and musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain); Frequency of deaths, serious adverse events (SAEs), discontinuations due to Adverse Events (AEs), dose reductions, and severity Grade 3/4 laboratory abnormalities; Absolute and percent change from baseline in the CD4 cell count, lymphocyte cell count, and platelet count

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